BAM Trial
Description
Describe your research hypothesis, what your data shows, any notable findings and how the data can be interpreted. Please add sufficient description to enable others to understand what the data is, how it was gathered and how to interpret and use it.
Files
Steps to reproduce
This data originates from a registered, ethics-approved RCT. 163 nulliparous women in active labor were randomized (1:1 via www.StudyRandomizer.com, concealed envelopes) to peanut ball + standard care (intervention) or standard care alone (control). Methods & Instruments: Intervention: A standardized PVC peanut ball was used per protocol (30min/2h, specific positions). Primary Data: Collected during labor at three cervical dilation points (<5cm, 5-7cm, 8-10cm) using: VAS (Visual Analog Scale): For self-reported pain (0-10). VAS-A: For self-reported anxiety (0-10). Secondary Data: Collected postpartum via validated questionnaires: PASS-20: For pain-related anxiety. W-DEQ: For fear of childbirth. BMSP-2: For maternal well-being. Clinical Outcomes: Labor duration, oxytocin use, delivery mode, and neonatal Apgar scores were extracted from medical records. Workflow & Software: Blinding: Outcome assessors and data analysts were blinded to group allocation. Analysis: Data was anonymized, entered into CRFs, and analyzed using IBM SPSS Statistics v26. Analyses included descriptive statistics, t-tests, Mann-Whitney U, chi-square, and repeated-measures ANOVA. This protocol ensures the data is reproducible for replication or meta-analysis.
Institutions
- Universidad Nacional Autonoma de Honduras